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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K854122
Device Name PRECIOUS LITE MODEL 4224
Applicant
E & B Technologies, Inc.
4035 Oceanside Blvd-C-16
P.O. Box 6377
Oceanside,  CA  92056
Applicant Contact ED BURLESON
Correspondent
E & B Technologies, Inc.
4035 Oceanside Blvd-C-16
P.O. Box 6377
Oceanside,  CA  92056
Correspondent Contact ED BURLESON
Regulation Number880.5700
Classification Product Code
LBI  
Date Received10/09/1985
Decision Date 02/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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